[Federal Register Volume 70, Number 19 (Monday, January 31, 2005)]
[Notices]
[Pages 4853-4857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1814]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0441]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for Food
and Drug Administration Approval to Market a New Drug
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by March
2, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
[[Page 4854]]
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Application for FDA Approval to Market a New Drug--(OMB Control Number
0910-0001)--Extension
Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(a)), a new drug may not be commercially
marketed in the United States, imported, or exported from the United
States, unless an approval of an application filed with FDA under
section 505(b) or 505(j) of the act is effective with respect to such
drug. Section 505(b) and 505(j) of the act requires a sponsor to submit
to FDA a new drug application (NDA) containing, among other things,
full reports of investigations that show whether or not the drug is
safe and effective for use, a full list of articles used as components
in the drug, a full description of manufacturing methods, samples of
the drugs required, specimens of the labeling proposed to be used, and
certain patent information as applicable. Under the act, it is the
sponsor's responsibility to provide the information needed by FDA to
make a scientific and technical determination that the product is safe
and effective.
This information collection approval request is for all information
requirements imposed on sponsors by the regulations under part 314 (21
CFR 314), who apply for approval of a new drug application in order to
market or to continue to market a drug.
Section 314.50(a) requires that an application form (Form FDA 356h)
be submitted that includes introductory information about the drug as
well as a checklist of enclosures.
Section 314.50(b) requires that an index be submitted with the
archival copy of the application and that it reference certain sections
of the application.
Section 314.50(c) requires that a summary of the application be
submitted that presents a good general synopsis of all the technical
sections and other information in the application.
Section 314.50(d) requires that the NDA contain the following
technical sections about the new drug: Chemistry, manufacturing, and
controls; nonclinical pharmacology and toxicology; human
pharmacokinetics and bioavailability; microbiology; clinical data; and
statistical section.
Section 314.50(e) requires the applicant to submit samples of the
drug if requested by FDA. In addition, the archival copy of the
application must include copies of the label and all labeling for the
drug.
Section 314.50(f) requires that case report forms and tabulations
be submitted with the archival copy.
Section 314.50(h) requires that patent information, as described
under Sec. 314.53, be submitted with the application.
Section 314.50(i) requires that patent certification information be
submitted in section 505(b)(2) applications for patents claiming the
drug, drug product, method of use, or method of manufacturing.
Section 314.50(j) requires that applicants that request a period of
marketing exclusivity submit certain information with the application.
Section 314.50(k) requires that an archival, review, and field copy
of the application be submitted.
Section 314.52 requires that notice of certification of invalidity
or noninfringement of a patent to patent holders and NDA holders be
sent by section 505(b)(2) applicants.
Section 314.54 sets forth the content requirements for applications
filed under section 505(b)(2) of the act.
Section 314.60 sets forth reporting requirements for sponsors who
amend an unapproved application.
Section 314.65 states that the sponsor must notify FDA when
withdrawing an unapproved application.
Sections 314.70 and 314.71 require that supplements be submitted to
FDA for certain changes to an approved application.
Section 314.72 requires sponsors to report to FDA any transfer of
ownership of an application.
Section 314.80(c)(1) and (c)(2) sets forth requirements for
expedited adverse drug experience postmarketing reports and followup
reports, as well as for periodic adverse drug experience postmarketing
reports (Form FDA 3500A). (The burden hours for Sec. 314.80(c)(1) and
(c)(2) are already approved by OMB under OMB control numbers 0910-0230
and 0910-0291 and are not included in the hour burden estimates in
table 1 of this document.)
Section 314.80(i) establishes recordkeeping requirements for
reports of postmarketing adverse drug experiences. (The burden hours
for Sec. 314.80(i) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the hour burden
estimates in table 1 of this document.)
Section 314.81(b)(1) requires that field alert reports be submitted
to FDA (Form FDA 3331).
Section 314.81(b)(2) requires that annual reports be submitted to
FDA (Form FDA 2252). This form has been revised as a result of the
requirements in the final rule ``Postmarketing Studies for Approved
Human Drug and Licensed Biological Products; Status Reports,''
published in the Federal Register of October 30, 2000 (65 FR 64607).
The rule describes the types of postmarketing studies covered by the
status reports, the information to be included in the reports, and the
type of information that FDA would consider appropriate for public
disclosure. The rule implemented section 130(a) of the Food and Drug
Administration Modernization Act of 1997 (FDAMA). The changes to the
form include adding new spaces for the new status reports, reporting
for biological products, and editorial changes.
Section 314.81(b)(3)(i) requires that drug advertisements and
promotional labeling be submitted to FDA (Form FDA 2253).
Section 314.81(b)(3)(iii) sets forth reporting requirements for
sponsors who withdraw an approved drug product from sale. (The burden
hours for Sec. 314.81(b)(3)(iii) are already approved by OMB under OMB
control number 0910-0045 and are not included in the hour burden
estimates in table 1 of this document.)
Section 314.90 sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec. 314.50 through 314.81.
(The information collection hour burden estimate for NDA waiver
requests is included in table 1 of this document under estimates for
Sec. Sec. 314.50, 314.60, 314.70 and 314.71.)
Section 314.93 sets forth requirements for submitting a suitability
petition in accordance with Sec. 10.20 (21 CFR 10.20) and Sec. 10.30.
(The burden hours for Sec. 314.93 are already approved by OMB under
0910-0183 and are not included in the hour burden estimates in table 1
of this document.)
Section 314.94(a) and (d) requires that an ANDA contain the
following information: Application form; table of contents; basis for
ANDA submission; conditions of use; active ingredients; route of
administration, dosage form, and strength; bioequivalence; labeling;
chemistry, manufacturing, and controls; samples; patent certification.
Section 314.95 requires that notice of certification of invalidity
or noninfringement of a patent to patent
[[Page 4855]]
holders and NDA holders be sent by ANDA applicants.
Section 314.96 sets forth requirements for amendments to an
unapproved ANDA.
Section 314.97 sets forth requirements for submitting supplements
to an approved ANDA for changes that require FDA approval.
Section 314.98(a) sets forth postmarketing adverse drug experience
reporting and recordkeeping requirements for ANDAs. (The burden hours
for Sec. 314.98(a) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the hour burden
estimates in table 1 of this document.)
Section 314.98(c) requires other postmarketing reports for ANDAs:
Field alert reports (Form FDA 3331), annual reports (Form FDA 2252),
and advertisements and promotional labeling (Form FDA 2253). (The
information collection hour burden estimate for field alert reports is
included in table 1 of this document under Sec. 314.81(b)(1); the
estimate for annual reports is included under Sec. 314.81(b)(2); the
estimate for advertisements and promotional labeling is included under
Sec. 314.81(b)(3)(i).)
Section 314.99(a) requires that sponsors comply with certain
reporting requirements for withdrawing an unapproved ANDA and for a
change in ownership of an ANDA.
Section 314.99(b) sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec. 314.92 through 314.99.
(The information collection hour burden estimate for ANDA waiver
requests is included in table 1 of this document under estimates for
Sec. 314.94(a) and (d) and Sec. Sec. 314.96 and 314.97.)
Section 314.101(a) states that if FDA refuses to file an
application, the applicant may request an informal conference with FDA
and request that the application be filed over protest.
Section 314.107(c)(4) requires notice to FDA by ANDA or section
505(b)(2) application holders of any legal action concerning patent
infringement.
Section 314.107(e)(2)(iv) requires that an applicant submit a copy
of the entry of the order or judgment to FDA within 10 working days of
a final judgment.
Section 314.107(f) requires that ANDA or section 505(b)(2)
applicants notify FDA of the filing of any legal action filed within 45
days of receipt of the notice of certification. A patent owner may also
notify FDA of the filing of any legal action for patent infringement.
The patent owner or approved application holder who is an exclusive
patent licensee must submit to FDA a waiver that waives the opportunity
to file a legal action for patent infringement.
Section 314.110(a)(3) and (a)(4) states that, after receipt of an
FDA approvable letter, an applicant may request an opportunity for a
hearing on the question of whether there are grounds for denying
approval of the application. (The burden hours for Sec. 314.110(a)(3)
and (a)(4) are included under parts 10 through 16 (21 CFR part 16)
hearing regulations, in accordance with Sec. 314.201, and are not
included in the hour burden estimates in table 1 of this document.)
Section 314.110(a)(5) states that, after receipt of an approvable
letter, an applicant may notify FDA that it agrees to an extension of
the review period so that it can determine whether to respond further.
Section 314.110(b) states that, after receipt of an approvable
letter, an ANDA applicant may request an opportunity for a hearing on
the question of whether there are grounds for denying approval of the
application. (The burden hours for Sec. 314.110(b) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, and are not included in the hour burden estimates in table 1
of this document.)
Section 314.120(a)(3) states that, after receipt of a not
approvable letter, an applicant may request an opportunity for a
hearing on the question of whether there are grounds for denying
approval of the application. (The burden hours for Sec. 314.120(a)(3)
are included under parts 10 through 16 hearing regulations, in
accordance with Sec. 314.201, and are not included in the hour burden
estimates in table 1 of this document.)
Section 314.120(a)(5) states that, after receipt of a not
approvable letter, an applicant may notify FDA that it agrees to an
extension of the review period so that it can determine whether to
respond further.
Section 314.122(a) requires that an ANDA or a suitability petition
that relies on a listed drug that has been voluntarily withdrawn from
sale must be accompanied by a petition seeking a determination whether
the drug was withdrawn for safety or effectiveness reasons. (The burden
hours for Sec. 314.122(a) are already approved by OMB under OMB
control number 0910-0183 and are not included in the hour burden
estimates in table 1 of this document.)
Section 314.122(d) sets forth requirements for relisting petitions
for unlisted discontinued products. (The burden hours for Sec.
314.122(d) are already approved by OMB under OMB control number 0910-
0183 and are not included in the hour burden estimates in table 1 of
this document.)
Section 314.126(c) sets forth requirements for a petition to waive
criteria for adequate and well-controlled studies. (The burden hours
for Sec. 314.126(c) are already approved by OMB under 0910-0183 and
are not included in the hour burden estimates in table 1 of this
document.)
Section 314.151(a) and (b) set forth requirements for the
withdrawal of approval of an ANDA and the applicant's opportunity for a
hearing and submission of comments. (The burden hours for Sec.
314.151(a) and (b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec. 314.201, and are not included in
the hour burden estimates in table 1 of this document.)
Section 314.151(c) sets forth the requirements for withdrawal of
approval of an ANDA and the applicant's opportunity to submit written
objections and participate in a limited oral hearing. (The burden hours
for Sec. 314.151(c) are included under parts 10 through 16 hearing
regulations, in accordance with Sec. 314.201, and are not included in
the hour burden estimates in table 1 of this document.)
Section 314.152(b) sets forth the requirements for suspension of an
ANDA when the listed drug is voluntarily withdrawn for safety and
effectiveness reasons, and the applicant's opportunity to present
comments and participate in a limited oral hearing. (The burden hours
for Sec. 314.152(b) is included under parts 10 through 16 hearing
regulations, in accordance with Sec. 314.201, and is not included in
the hour burden estimates in table 1 of this document.)
Section 314.161(b) and (e) sets forth the requirements for
submitting a petition to determine whether a listed drug was
voluntarily withdrawn from sale for safety or effectiveness reasons.
(The burden hours for Sec. 314.161(b) and (e) are already approved by
OMB under OMB control number 0910-0183 and are not included in the hour
burden estimates in table 1 of this document.)
Section 314.200(c), (d), and (e) requires that applicants or others
subject to a notice of opportunity for a hearing who wish to
participate in a hearing file a written notice of participation and
request for a hearing as well as the studies, data, and so forth,
relied on. Other interested persons may also submit comments on the
notice. This section also sets forth the content and format
requirements for the applicants' submission in response to notice of
[[Page 4856]]
opportunity for hearing. (The burden hours for Sec. 314.200(c), (d),
and (e) are included under parts 10 through 16 hearing regulations, in
accordance with Sec. 314.201, and are not included in the hour burden
estimates in table 1 of this document.)
Section 314.200(f) states that participants in a hearing may make a
motion to the presiding officer for the inclusion of certain issues in
the hearing. (The burden hours for Sec. 314.200(f) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, and are not included in the hour burden estimates in table 1
of this document.)
Section 314.200(g) states that a person who responds to a proposed
order from FDA denying a request for a hearing provide sufficient data,
information, and analysis to demonstrate that there is a genuine and
substantial issue of fact which justifies a hearing. (The burden hours
for Sec. 314.200(g) are included under parts 10 through 16 hearing
regulations, in accordance with Sec. 314.201, and is not included in
the hour burden estimates in table 1 of this document.)
Section 314.420 states that an applicant may submit to FDA a drug
master file in support of an application, in accordance with certain
content and format requirements.
Section 314.430 states that data and information in an application
are disclosable under certain conditions, unless the applicant shows
that extraordinary circumstances exist. (The burden hours for Sec.
314.430 is included under parts 10 through 16 hearing regulations, in
accordance with Sec. 314.201, and is not included in the hour burden
estimates in table 1 of this document.)
Section 314.530(c) and (e) states that, if FDA withdraws approval
of a drug approved under the accelerated approval procedures, the
applicant has the opportunity to request a hearing and submit data and
information. (The burden hours for Sec. 314.530(c) and (e) are
included under parts 10 through 16 hearing regulations, in accordance
with Sec. 314.201, and are not included in the hour burden estimates
in table 1 of this document.)
Section 314.530(f) requires that an applicant first submit a
petition for stay of action before requesting an order from a court for
a stay of action pending review. (The burden hours for Sec. 314.530(f)
are already approved by OMB under 0910-0194 and are not included in the
hour burden estimates in table 1 of this document.)
In the Federal Register of October 8, 2004 (69 FR 60402), FDA
announced an opportunity for public comment on these information
collection estimates. No comments were submitted that pertained to the
information collection estimates in the October 8, 2004, document.
Respondents to this collection of information are all persons who
submit an application or abbreviated application or an amendment or
supplement to FDA under part 314 to obtain approval of a new drug, and
any person who owns an approved application or abbreviated application.
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Responses per Total Annual
21 CFR Section; [FDA Form Number] No. of Respondents Respondent Responses Hours Per Response Total Hours
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314.50 (a), (b), (c), (d), (e), (f), (h), 72 1.44 104 1,642 170,768
and (k)
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314.50(i) and 314.94(a)(12) 194 2.34 454 2 908
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314.50(j) 70 3.71 260 2 520
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314.52 and 314.95 24 2.25 54 16 864
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314.54 16 1 16 300 4,800
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314.60 275 19.06 5,242 80 419,320
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314.65 10 1 10 2 20
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314.70 and 314.71 234 10.99 2,572 150 385,800
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314.72 61 4.52 276 2 552
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314.81(b)(1) [3331] 115 3.88 447 8 3,576
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314.81(b)(2) [2252] 612 12.47 7,632 40 305,280
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314.81(b)(3)(i) [2253] 332 44.09 14,638 2 29,276
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314.94(a) and (d) 100 4.59 459 480 220,320
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314.96 275 23.63 6,500 80 520,000
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314.97 200 16.75 3,350 80 268,000
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314.99(a) 44 2.02 89 2 178
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314.101(a) 2 1 2 .50 1
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[[Page 4857]]
314.107(c)(4), 314.107(e)(2)(iv), and 3 2 6 1 6
314.107(f)
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314.110(a)(5) 41 1.26 52 .50 26
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314.120(a)(5) 12 1.16 14 .50 7
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314.420 403 1.72 694 61 42,334
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Total 2,372,556
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1814 Filed 1-27-05; 12:53 pm]
BILLING CODE 4160-01-S